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NCT06180187 Clinical Trial

Densah Burs vs. Electrical Mallet in Closed Sinus Lifting.

Alveolar Bone Loss Clinical Trial

Official title:
Radiographic and Clinical Comparative Study Between Osseodensification Burs and Electrical Mallet in Closed Sinus Floor Elevation and Simultaneous Implant Placement. Prospective Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06180187
Other study ID # 1222023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2023
Est. completion date March 2025

Study information
Verified date December 2023
Source Fayoum University
Contact abdelrahman S mostafa
Phone 1060641063
Email as3059@fayoum.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the comparative study is to evaluate the density and amount of new bone formed (bone height gain)around dental implant placed simultaneously in posterior maxilla after closed sinus floor elevation using Osseodensification burs versus electrical mallet.

Description:

Extraction of posterior teeth in the maxilla for long time without rehabilitation of the area increases the incidence of maxillary sinus pneumatization that makes maxillary sinus enlarges in volume over the residual bone of alveolar ridge. Decreasing the height of sub_ antral bone affects adversely on the bone density which is crucial for implant primary stability causing placement of dental implant quite challenging requiring sinus lifting procedure and bone condensation of residual ridge in addition to bone grafting Summers technique considered the gold standard for closed sinus floor elevation using osteotome and a hand mallet to condense alveolar bone and elevate schneiderian membrane. One of drawbacks of this technique is benign paroxysmal positional vertigo due to force applied by hand mallet is not controlled. Electrical mallet was introduced to overcome (BPPV) as it applies controlled force (daN) in short fraction of seconds(µs) with hand piece secured totally by the surgeon and have a wide variety of instruments placed on the hand piece e.g. osteotomes used in sinus floor elevation . Controlled force of magnetic mallet decrees the risk of schneiderian membrane perforation Osseodensification burs now show great outcomes in closed sinus lifting procedure. Densah burs increase the density of alveolar bone which increase the primary stability of dental implants . Aim of this study is to compare Electrical mallet with Osseodensification burs in closed sinus lifting.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date March 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients with partially edentulous posterior maxilla - Residual bone height = 5mm - Oral hygiene : fair oral hygiene Exclusion Criteria: - Smoking - Systematic disease that affects bone remodeling (e.g. uncontrolled Diabetes mellitus or osteoporosis) - Radiotherapy to head and neck or chemotherapy - Chronic disease of maxillary sinus

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Electrical mallet
elevation of the Schneiderian membrane of maxillary sinus using electrical mallet and place bone graft material to augment the residual alveolar ridge and then place dental implant .
• Osseo-densification burs
elevation of the Schneiderian membrane of maxillary sinus using osseodensification burs and place bone graft material to augment the residual alveolar ridge and then place dental implant .

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fayoum University

Outcome
Type Measure Description Time frame Safety issue
Primary bone height gain Evaluate the change in bone height radiographically after closed sinus floor elevation and simultaneous implant placement .using cone beam computed tomography immediate after surgery and 6 months post operative . 6 months follow up
Primary change in bone density Evaluate the amount of change in bone density around dental implant immediately post operative and after 6 months. 6 months follow up
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